Viewing data from:

ORETON METHYL

NDA

METHYLTESTOSTERONE | N003158 | SCHERING CORP SUB SCHERING PLOUGH CORP

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from ICN Pharmaceuticals, Inc. FDA-1993-P-0062 ICN Pharmaceuticals, Inc. filed this petition under 21 CFR 10.30, 25.31, and 314.93 requesting FDA approval to change the dosage form of methyltestosterone from the listed drug ORETON METHYL 25 mg tablets to allow filing of an Abbreviated New Drug Application for TESTRED 25 mg capsules, with ICN pro	Other	2017-05-23	Withdrawn	ICN Pharmaceuticals

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Methitest (2023)

Total Spending

$222K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$75.55

Spending Trend

$147K(2019)→$75K(2020)→$117K(2021)→$99K(2022)→$222K(2023)

YoY Change:+9.1%

5yr CAGR:+1.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs5 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

ASPEN OSS BVMETHYLTESTOSTERONE

DMF 38611980

FARMABIOS SPAMETHYLTESTOSTERONE (MICRONIZED)

DMF 255932011

NOVITIUM PHARMA LLCMETHYLTESTOSTERONE USP

DMF 343732019

KV PHARMACEUTICAL COInactiveMETHYLTESTOSTERONE

DMF 23101974

ROUSSELL UCLAFInactiveMETHYLTESTOSTERONE USP

DMF 37751980

SCHERING AGInactiveMETHYLTESTOSTERONE

DMF 47041982

SYNTEX USA INCInactiveMETHYLTESTOSTERONE

DMF 66791986

HENAN QUANXIN MEDICAL CHEMICAL TECHNOLOGY CO LTDInactiveMETHYLTESTOSTERONE USP

DMF 188042005

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

Sort:

#001 — 10MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 25MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982